Brand Name

Levemir

Generic Name
Detemir
View Brand Information
FDA approval date: March 27, 2006
Classification: Insulin Analog
Form: Injection

What is Levemir (Detemir)?

LEVEMIR is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use LEVEMIR is not recommended for the treatment of diabetic ketoacidosis. LEVEMIR is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus . Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis.

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Brand Information

LEVEMIR (insulin detemir)
1INDICATIONS AND USAGE
LEVEMIR is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
Limitations of Use
LEVEMIR is not recommended for the treatment of diabetic ketoacidosis.
2DOSAGE FORMS AND STRENGTHS
Injection: 100 units/mL (U-100), is a clear, colorless, solution available as:
  • 3 mL single-patient-use FlexPen prefilled pen
  • 10 mL multiple-dose vial
3CONTRAINDICATIONS
LEVEMIR is contraindicated:
  • During episodes of hypoglycemia
  • In patients with hypersensitivity to insulin detemir or any of the excipients in LEVEMIR. Reactions have included anaphylaxis
4ADVERSE REACTIONS
The following adverse reactions are discussed elsewhere:
  • Hypoglycemia
  • Hypoglycemia Due to Medication errors
  • Hypersensitivity Reactions
  • Hypokalemia
4.1Clinical Trial Experience
Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.
The frequencies of adverse reactions (excluding hypoglycemia) reported during LEVEMIR clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in Tables 1-4 below. See Tables 5 and 6 for the hypoglycemia findings.
In two pooled trials, adults with type 1 diabetes were exposed to individualized doses of LEVEMIR (n=767) or NPH (n=388). The mean duration of exposure to LEVEMIR was 153 days, and the total exposure to LEVEMIR was 321 patient-years. The most common adverse reactions are summarized in Table 1.
Adults with type 1 diabetes were exposed to LEVEMIR (n=161) or insulin glargine (n=159). The mean duration of exposure to LEVEMIR was 176 days, and the total exposure to LEVEMIR was 78 patient-years. The most common adverse reactions are summarized in Table 2.
In two pooled trials, adults with type 2 diabetes were exposed to LEVEMIR (n=432) or NPH (n=437). The mean duration of exposure to LEVEMIR was 157 days, and the total exposure to LEVEMIR was 186 patient-years. The most common adverse reactions were comparable to that observed in adult patients with type 1 diabetes mellitus; see Table 1.
Pediatric patients with type 1 diabetes were exposed to individualized doses of LEVEMIR (n=232) or NPH (n=115). The mean duration of exposure to LEVEMIR was 180 days, and the total exposure to LEVEMIR was 114 patient-years. The most common adverse reactions are summarized in Table 3.
Hypoglycemia
Hypoglycemia was the most commonly observed adverse reaction in patients treated with LEVEMIR. The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for LEVEMIR with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that will occur in clinical practice.
Table 4 (type 1 diabetes) and Table 5 (type 2 diabetes) summarize the incidence of severe and non-severe hypoglycemia in the LEVEMIR clinical trials.
For the adult trials and one of the pediatric trials (Study D), severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring assistance of another person and associated with either a plasma glucose value below 56 mg/dL (blood glucose below 50 mg/dL) or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration. For the other pediatric trial (Study I), severe hypoglycemia was defined as an event with semi-consciousness, unconsciousness, coma and/or convulsions in a patient who could not assist in the treatment and who may have required glucagon or intravenous glucose.
For the adult trials and pediatric trial (Study D), non-severe hypoglycemia was defined as an asymptomatic or symptomatic plasma glucose <56 mg/dL (or equivalently blood glucose <50 mg/dL as used in Study A and C) that was self-treated by the patient. For pediatric Study I, non-severe hypoglycemia included asymptomatic events with plasma glucose <65 mg/dL as well as symptomatic events that the patient could self-treat or treat by taking oral therapy provided by the caregiver.
  • Hypersensitivity Reactions
  • Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock have occurred with insulin, including LEVEMIR, and may be life-threatening.
Insulin Initiation and Intensification of Glucose Control
Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.
Lipodystrophy
Long-term use of insulin, including LEVEMIR, can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption
Weight Gain
Weight gain can occur with insulin therapy, including LEVEMIR, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria
Peripheral Edema
Insulin, including LEVEMIR, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Injection Site Reactions
Patients taking LEVEMIR may experience injection site reactions, including localized erythema, pain, pruritus, urticaria, edema, and inflammation. In clinical studies in adults, three patients treated with LEVEMIR reported injection site pain (0.25%).
Immunogenicity
All insulin products can elicit the formation of insulin antibodies. These insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose. In clinical trials of LEVEMIR, antibody development has been observed with no apparent impact on glycemic control.
4.2Postmarketing Experience
The following adverse reactions have been identified during post approval use of LEVEMIR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Medication errors have been reported in which rapid-acting or short-acting insulins and other insulins, have been accidentally administered instead of LEVEMIR.
Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
5DRUG INTERACTIONS
Table 6 includes clinically significant drug interactions with LEVEMIR.
Table 6: Clinically Significant Drug Interactions with LEVEMIR
6OVERDOSAGE
An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia and hypokalemia
7DESCRIPTION
Insulin detemir is a long-acting recombinant human insulin analog produced by a process that includes expression of recombinant DNA in
Insulin detemir differs from human insulin in that the amino acid threonine in position B30 has been omitted, and a C14 fatty acid chain has been attached to the amino acid B29. Insulin detemir has a molecular formula of C
Figure 1: Structural Formula of Insulin Detemir
Levemir Chemical Structure.jpg
LEVEMIR (insulin detemir) injection is a clear, colorless, aqueous, neutral sterile solution for subcutaneous use. Each milliliter of LEVEMIR contains 100 units insulin detemir, dibasic sodium phosphate (0.71 mg), glycerin (16 mg), metacresol (2.06 mg), phenol (1.8 mg), sodium chloride (1.17 mg), zinc (65.4 mcg), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. LEVEMIR has a pH of approximately 7.4.
8CLINICAL STUDIES
The efficacy and safety of LEVEMIR given once-daily at bedtime or twice-daily (before breakfast and at bedtime, before breakfast and with the evening meal, or at 12-hour intervals) was compared to that of once-daily or twice-daily NPH insulin in open-label, randomized, parallel trials of 1155 adults with type 1 diabetes mellitus, 347 pediatric patients with type 1 diabetes mellitus, and 869 adults with type 2 diabetes mellitus. The efficacy and safety of LEVEMIR given twice-daily was compared to once-daily insulin glargine in an open-label, randomized, parallel trial of 320 patients with type 1 diabetes. The evening LEVEMIR dose was titrated in all trials according to pre-defined targets for fasting blood glucose. The pre-dinner blood glucose was used to titrate the morning LEVEMIR dose in those trials that also administered LEVEMIR in the morning. In general, the reduction in HbA
8.1Clinical Studies in Adult Patients with Type 1 Diabetes
In a 16-week open-label clinical trial (Study A, n=409), adults with type 1 diabetes were randomized to treatment with either LEVEMIR at 12-hour intervals, LEVEMIR administered in the morning and bedtime or NPH insulin administered in the morning and bedtime. Insulin aspart was also administered before each meal. At 16 weeks of treatment, the combined LEVEMIR-treated patients had similar HbA
In a 26-week, open-label clinical trial (Study B, n=320), adults with type 1 diabetes were randomized to twice-daily LEVEMIR (administered in the morning and bedtime) or once-daily insulin glargine (administered at bedtime). Insulin aspart was administered before each meal. LEVEMIR-treated patients had a decrease in HbA
In a 24-week, open-label clinical trial (Study C, n=749), adults with type 1 diabetes were randomized to once-daily LEVEMIR or once-daily NPH insulin, both administered at bedtime and in combination with regular human insulin before each meal. LEVEMIR and NPH insulin had a similar effect on HbA
*From an ANCOVA model adjusted for baseline value and country.
**From an ANCOVA model adjusted for baseline value and study site.
8.2Clinical Studies in Pediatric Patients with Type 1 Diabetes
Two open-label, randomized, controlled clinical trials have been conducted in pediatric patients with type 1 diabetes. One trial (Study D) was 26 weeks in duration and enrolled patients 6 to 17 years of age. The other trial (Study I) was 52 weeks in duration and enrolled patients 2 to 16 years of age. In both trials, LEVEMIR and NPH insulin were administered once- or twice-daily. Bolus insulin aspart was administered before each meal. In the 26-week trial, LEVEMIR-treated patients had a mean decrease in HbA
*From an ANCOVA model adjusted for baseline value, geographical region, gender and age (covariate).
**From an ANCOVA model adjusted for baseline value, country, pubertal status at baseline and age (stratification factor).
8.3Clinical Studies in Adult Patients with Type 2 Diabetes
In a 24-week, open-label, randomized, clinical trial (Study E, n=476), LEVEMIR administered twice-daily (before breakfast and evening) was compared to NPH insulin administered twice-daily (before breakfast and evening) as part of a regimen of stable combination therapy with one or two of the following oral antidiabetic medications: metformin, an insulin secretagogue, or an alpha–glucosidase inhibitor. All patients were insulin-naïve at the time of randomization. LEVEMIR and NPH insulin similarly lowered HbA
In a 22-week, open-label, randomized, clinical trial (Study F, n=395) in adults with type 2 diabetes, LEVEMIR and NPH insulin were given once- or twice-daily as part of a basal-bolus regimen with insulin aspart. As measured by HbA
Table 9: Type 2 Diabetes Mellitus – Adult
1Study F - Fasting blood glucose data not collected
*From an ANCOVA model adjusted for baseline value, country and oral antidiabetic treatment category.
**From an ANCOVA model adjusted for baseline value and country.
Combination Therapy with Metformin and Liraglutide
This 26-week open-label trial enrolled 988 patients with inadequate glycemic control (HbA
Treatment with LEVEMIR as add-on to liraglutide 1.8 mg + metformin resulted in statistically significant reductions in HbA
Table 10: Results of a 26-week Open-label Trial of LEVEMIR as Add-on to Liraglutide + Metformin Compared to Continued Treatment with Liraglutide + Metformin Alone in Patients Not Achieving HbA
aIntent-to-treat population using last observation on study
bLeast squares mean adjusted for baseline value
*From an ANCOVA model adjusted for baseline value, country and previous oral antidiabetic treatment category.
**From a logistic regression model adjusted for baseline HbA
***p-value <0.0001
9HOW SUPPLIED/STORAGE AND HANDLING
Product: 50090-6391
NDC: 50090-6391-0 3 mL in a SYRINGE, PLASTIC / 5 in a CARTON
10PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling (Patient Information and Instructions for Use). There are separate Instructions for Use for the Vials and LEVEMIR FlexPen Prefilled Pen.
Never Share a LEVEMIR FlexPen or Insulin Syringe Between Patients
Advise patients that they must never share a LEVEMIR FlexPen with another person, even if the needle is changed. Advise patients using LEVEMIR vials not to share needles or insulin syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens
Hyperglycemia or Hypoglycemia
Inform patients that hypoglycemia is the most common adverse reaction with insulin. Inform patients of the symptoms of hypoglycemia (e.g., impaired ability to concentrate and react). This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery
Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision
Hypersensitivity Reactions
Advise patients that hypersensitivity reactions have occurred with LEVEMIR. Inform patients on the symptoms of hypersensitivity reactions
Hypoglycemia Due to Medication Errors
Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products
Novo Nordisk®, Levemir®, NovoLog®, FlexPen, and NovoFine
Patent Information: https://www.novonordisk-us.com/products/product-patents.html
© 2005-2022 Novo Nordisk
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
U.S. License Number 1261
For information about LEVEMIR contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, New Jersey 08536
1-800-727-6500
www.novonordisk-us.com
11Patient Information
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 12/2022
INSTRUCTIONS FOR USE
LEVEMIR® (LEV-uh-mere)
injection, for subcutaneous use
10 mL multiple-dose vial
Please read the following Instructions for use carefully before using your LEVEMIR
How should I use the LEVEMIR vial?
Using the vial:
How should I inject LEVEMIR with a syringe?
If you clean your injection site with an alcohol swab, let the injection site dry before you inject. Talk with your healthcare provider about how to rotate injection sites and how to give an injection.
Revised: 07/2022
Novo Nordisk.
PATENT Information: https://www.novonordisk-us.com/products/product-patents.html
© 2005-2022 Novo Nordisk
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
U.S. License Number 1261
INSTRUCTIONS FOR USE
Levemir
(insulin detemir)
injection, for subcutaneous use
FlexTouch
Please read the following instructions carefully before using your Levemir FlexTouch Pen.
  • Do not share your Levemir FlexTouch Pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
  • Levemir FlexTouch Pen (“Pen”) is a prefilled disposable, single-patient-use insulin pen containing 300 units insulin detemir. You can inject from 1 to 80 units in a single injection.
  • People who are blind or have vision problems should not use this Pen without help from a person trained to use the Pen.
Supplies you will need to give your Levemir injection:
  • Levemir FlexTouch Pen
  • a new NovoFine, NovoFine Plus or NovoTwist needle
  • alcohol swab
  • 1 sharps container for throwing away used Pens and needles.
Preparing your Levemir FlexTouch Pen:
  • Wash your hands with soap and water.
  • Before you start to prepare your injection, check the Levemir FlexTouch Pen label to make sure you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin.
  • Levemir should look clear and colorless.
  • Do not use Levemir past the expiration date printed on the label or 42 days after you start using the Pen.
  • Always use a new needle for each injection to help ensure sterility and prevent blocked needles. Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.
Needle components.Figure A FlexTouch pen components.
Priming your Levemir FlexTouch Pen:
Selecting your dose:
Giving your injection:
  • Inject your Levemir exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
  • Levemir can be injected under the skin (subcutaneously) of your stomach area (abdomen), upper legs (thighs) or upper arms.
  • For each injection, change (rotate) your injection site within the area of skin that you use to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
After your injection:
  • The used Levemir FlexTouch Pen may be thrown away in your household trash after you have removed the needle.
  • You can put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. Do not reuse or share your needles or syringes with other people. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at:
  • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
How should I store my Levemir FlexTouch Pen?
  • Store unused Levemir FlexTouch Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Store the Pen you are currently using out of the refrigerator up to 86°F.
  • Do not freeze Levemir. Do not use Levemir if it has been frozen.
  • Keep Levemir away from heat or light.
  • Unused Pens may be used until the expiration date printed on the label, if kept in the refrigerator.
  • The Levemir FlexTouch Pen you are using should be thrown away after 42 days, even if it still has insulin left in it.
General Information about the safe and effective use of Levemir:
  • Keep Levemir FlexTouch Pens and needles out of the reach of children.
  • Always use a new needle for each injection.
  • Do not share your Levemir FlexTouch Pen or needles with other people. You may give other people a serious infection, or get a serious infection from them.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
U.S. License Number 1261
Revised: 07/2022
FlexTouch QR Code
For more information go to
© 2005-2022 Novo Nordisk
Levemir
FlexTouch
Read before first use
Instructions For Use
LEVEMIR
(insulin detemir)
injection, for subcutaneous use
Please read the following instructions carefully before using your LEVEMIR FlexPen.
Do not share your LEVEMIR FlexPen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.
LEVEMIR FlexPen is a prefilled disposable, single-patient-use, insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. LEVEMIR FlexPen is designed to be used with NovoFine or NovoFine Plus needles.
Important message People who are blind or have vision problems should not use this Pen without help from a person trained to use the Pen.
Getting ready
Make sure you have the following items:
  • LEVEMIR FlexPen
  • NovoFine or NovoFine Plus disposable needles
  • Alcohol swab
  • Sharps disposal container (see
Image of components for Levemir FlexPen and needles.
Preparing your LEVEMIR FlexPen
Wash your hands with soap and water. Before you start to prepare your injection, check the label to make sure that you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin. LEVEMIR should look clear and colorless.
Important Always use a new needle for each injection to make sure the needle is free of germs (sterile) and to prevent blocked needles. Do not reuse or share your needles with other people. You may give other people a serious infection or get a serious infection from them.
Important Be careful not to bend or damage the needle before use.
Important message To reduce the risk of needle sticks, never put the inner needle cap back on the needle.
Giving the airshot before each injection
Before each injection, small amounts of air may collect in the cartridge during normal use. To avoid injecting air and to ensure proper dosing:
Selecting your dose
Check and make sure that the dose selector is set at 0.
Giving the injection
Give the injection exactly as shown to you by your healthcare provider. Your healthcare provider should tell you if you need to pinch the skin before injecting. Wipe the skin with an alcohol swab and let the area dry.
LEVEMIR can be injected under the skin (subcutaneously) of your stomach area (abdomen), upper legs (thighs), or upper arms.
Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
After the injection
Do not recap the needle. Recapping can lead to a needle stick injury. Remove the needle from the LEVEMIR FlexPen after each injection and dispose of it. This helps to prevent infection, leakage of insulin, and will help to make sure you inject the right dose of insulin.
  • If you do not have a sharps container, carefully slip the needle into the outer needle cap using 1 hand. Use your other hand to pinch the base of the big outer needle cap and unscrew the used needle from the Pen and throw it away as soon as you can.
  • The used LEVEMIR FlexPen may be thrown away in your household trash after you have removed the needle.
  • Put your used needles in an FDA-cleared sharps disposal container right away after use.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at:
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
When there is not enough medicine left in your LEVEMIR FlexPen for your prescribed dose, the LEVEMIR FlexPen may be thrown away in your household trash after you have removed the needle.
The LEVEMIR FlexPen prevents the cartridge from being completely emptied. It is designed to deliver 300 units.
How should I store LEVEMIR FlexPen?
  • Store the unused (unopened) LEVEMIR FlexPen in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Store the LEVEMIR FlexPen you are currently using out of the refrigerator up to 86°F.
  • Do not freeze the LEVEMIR FlexPen. Do not use the LEVEMIR FlexPen if it has been frozen.
  • Keep the LEVEMIR FlexPen away from heat or light.
  • Unused LEVEMIR FlexPens may be used until the expiration date printed on the label, if kept in the refrigerator.
The LEVEMIR FlexPen you are using should be thrown away after 42 days, even if it still has insulin left in it.
Keep your LEVEMIR FlexPen and needles out of the reach of children.
Maintenance
For the safe and proper use of your LEVEMIR FlexPen be sure to handle it with care. Avoid dropping your LEVEMIR FlexPen as it may damage it. If you are concerned that your LEVEMIR FlexPen is damaged, use a new one. You can clean the outside of your LEVEMIR FlexPen by wiping it with a damp cloth.
Important message Remove the needle from the LEVEMIR FlexPen after each injection. This helps to ensure sterility, prevent leakage of insulin, and will help to make sure you inject the right dose of insulin for future injections.
Important message Be careful when handling used needles to avoid needle sticks and transfer of infectious diseases.
Important message Use the LEVEMIR FlexPen exactly as your healthcare provider tells you to.
Important message Do not share your LEVEMIR FlexPen or needles with other people. You may give other people a serious infection, or get a serious infection from them.
Important message Always use a new needle for each injection.
Important message Novo Nordisk is not responsible for harm due to using this insulin pen with products not recommended by Novo Nordisk.
Important message As a precautionary measure, always carry a spare insulin delivery device in case your LEVEMIR FlexPen is lost or damaged.
Important message Remember to keep the disposable LEVEMIR FlexPen with you. Do not leave it in a car or other location where it can get too hot or too cold.
© 2022 Novo Nordisk
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
U.S. License Number 1261
Revised: 12/2022
12insulin detemir
Label Image